FDA requirements for Exempted Class I Medical Devices

P

pyrules

Dear All

This question is with regards to FDA registered medical devices in the US.

What are the requirements before an exempted Class I medical device is approved to be marketed in the US?

Are FDA approval letters issued for exempted Class I medical devices?

Many thanks in advance for the insights to the above questions.

Thanks & Regards
Pyrules
 
P

pyrules

Re: FDA Exempted Class I Medical Devices

Looks like the answer can be found at the FDA website. Under FDA Basics > What is the difference between FDA-listed, 510(k) exempt, cleared and approved medical devices?

510(k) exempt devices must
  • be suitable for their intended use
  • be adequately packaged and properly labeled
  • have establishment registration and device listing forms on file with FDA
  • be manufactured under a quality system (with the exception of a small number of class I devices that are subject only to complaint files and general recordkeeping requirements)
I reckoned that FDA approval letters are not issued in this case?
 

Ronen E

Problem Solver
Moderator
Re: FDA Exempted Class I Medical Devices

Looks like the answer can be found at the FDA website. Under FDA Basics > What is the difference between FDA-listed, 510(k) exempt, cleared and approved medical devices?


510(k) exempt devices must
  • be suitable for their intended use
  • be adequately packaged and properly labeled
  • have establishment registration and device listing forms on file with FDA
  • be manufactured under a quality system (with the exception of a small number of class I devices that are subject only to complaint files and general recordkeeping requirements)
I reckoned that FDA approval letters are not issued in this case?

Not as such.
Ronen.
 

Ronen E

Problem Solver
Moderator
Re: FDA Exempted Class I Medical Devices

Hi Ronen, many thanks for your reply.

Is it possible for you to elaborate?

The FDA doesn't issue "approval letters" for exempt class I devices; however, various FDA records would be able to serve as evidence that the subject device is cleared for marketing. For example: Listing records, Establishment inspection records (if and when you have an inspection in the future) etc.

Cheers,
Ronen.
 
P

pyrules

Re: FDA Exempted Class I Medical Devices

Hi Ronen, many thanks again for your insights and helpful reply.
 
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